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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12618001898246
Ethics application status
Approved
Date submitted
9/11/2018
Date registered
22/11/2018
Date last updated
23/06/2021
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Making it Personal: Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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Scientific title
Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Insights from N-of-1 Studies: A Series of N-of-1 Observational Studies
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Secondary ID [1]
296328
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
310038
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Condition category
Condition code
Other
308788
308788
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
ME/CFS is a complex, multi-system, neuroimmune condition with a multitude of symptoms. Some symptoms include post-exertional fatigue/malaise, sleep problems/disturbances, joint and muscle pain, headaches, short-term memory loss, impaired concentration, hypersensitivity to light and sound, emotional overload, problems with dizziness and balance, recurrent flu-like symptoms, gastrointestinal problems and sensitivities to food, medications, odours or certain chemicals. It is common for patients to experience post-exertional fatigue/malaise, but the particular cluster of symptoms experienced can differ considerably from one person to another. Factors such as physical/cognitive activity, sleep, stress and mood may trigger or worsen symptoms.
In this study, variables including physical/cognitive activity, sleep, stress, mood and fatigue are measured on a daily basis for period of 6-12 weeks via an electronic diary with an inbuilt accelerometer. Variables related to personally-relevant symptoms (e.g. body pain, headaches, dizziness) and potential triggers of symptoms (e.g. emotional distress, dehydration) are selected by participants at the start of the study and also added to the daily questionnaires.
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Intervention code [1]
312655
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
307771
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The severity of physical fatigue measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (n-of-1) level.
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Assessment method [1]
307771
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Timepoint [1]
307771
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Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
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Primary outcome [2]
308195
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The severity of cognitive fatigue measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (n-of-1) level.
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Assessment method [2]
308195
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Timepoint [2]
308195
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Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
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Secondary outcome [1]
352818
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The severity of a personally-relevant symptom (e.g. body pain, headaches, tinnitus, dizziness) selected by the participant at the start of the study measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (n-of-1) level. If more than one symptom is selected by the participant, it will be analysed as another secondary outcome (i.e. not a composite measure).
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Assessment method [1]
352818
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Timepoint [1]
352818
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Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
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Eligibility
Key inclusion criteria
Adults 18 years or older with a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Individuals are not excluded on the basis of their gender, age or overall health status.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Individuals under 18 years old. Individuals who have not received a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Statistical power in n-of-1 studies is determined by the number of repeated measurements from the same individual. Therefore, there are no sample size requirements related to the number of participants recruited.
Individual level and aggregated analyses will be performed. Individual level analyses will be conducted using Bayesian time series analysis. Aggregated analyses will be conducted using Bayesian hierarchical models.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/07/2021
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Actual
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Date of last participant enrolment
Anticipated
31/10/2022
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Actual
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Date of last data collection
Anticipated
31/12/2022
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
300924
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Self funded/Unfunded
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Name [1]
300924
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Suzanne McDonald
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Address [1]
300924
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The University of Queensland,
Centre for Clinical Research,
Building 71/918,
Royal Brisbane & Women's Hospital Campus
Herston,
Queensland,
4029
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Country [1]
300924
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
UQ Centre for Clinical Research
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston, QLD, 4029
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Country
Australia
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Secondary sponsor category [1]
300488
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None
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Name [1]
300488
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Address [1]
300488
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Country [1]
300488
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301696
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The University of Queensland Medicine Faculty Low or Negligible Risk Sub-Committee
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Ethics committee address [1]
301696
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Oral Health Centre
Level 6, Oral Health Centre (883),
288 Herston Road,
Herston,
Queensland
4006
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Ethics committee country [1]
301696
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Australia
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Date submitted for ethics approval [1]
301696
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03/07/2018
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Approval date [1]
301696
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10/07/2018
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Ethics approval number [1]
301696
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#2018000741
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Summary
Brief summary
This research study aims to explore intra-individual variability in symptoms over time and intra-individual predictors of symptom severity. A series of n-of-1 observational studies with individuals with ME/CFS will be conducted. The study also aims to assess the acceptability and feasibility of participating in n-of-1 observational studies from the perspective of individuals with ME/CFS. This will be achieved by conducting semi-structured interviews with participants at the end of the study and by examining participant adherence to study procedures (e.g. questionnaire completion rates).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
87806
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Dr Suzanne McDonald
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Address
87806
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UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
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Country
87806
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Australia
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Phone
87806
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+61733465025
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Fax
87806
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Email
87806
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[email protected]
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Contact person for public queries
Name
87807
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Dr Suzanne McDonald
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Address
87807
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UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
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Country
87807
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Australia
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Phone
87807
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+61733465025
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Fax
87807
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Email
87807
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[email protected]
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Contact person for scientific queries
Name
87808
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Dr Suzanne McDonald
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Address
87808
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UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
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Country
87808
0
Australia
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Phone
87808
0
+61733465025
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Fax
87808
0
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Email
87808
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All data collected from each participant is analysed at the individual level. Participants are informed that their data may be combined with other data at a future date (e.g. for meta-analysis) and provide consent for their data to be used in further research.
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When will data be available (start and end dates)?
Immediately following publication; no end date
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Available to whom?
Only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
For IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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